Open, ClassifiedPosted Aug 5, 2025·Initiated Jul 7, 2025
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Reason: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The
observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics IncType: Electrode, Ion Specific, SodiumDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bahrain, Bolivia, Brazil, Canada, Canary Islands, Chile, Croatia, Denmark, Ecuador, Estonia, France, Fren. Polynesia, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Caledonia, Paraguay, Philippines, Poland, Portugal, Qatar, Rep. Korea (S), Romania, Russian Fed., San Marino, Slovakia, Slovenia, South Africa, Spain, Srilanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, Unit.Arab Emir., United Kingdom, Uruguay, Japan.Recall #Z-2272-2025 Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
LAPAROSCOPIC TRAY. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2240-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
CARDIAC ROBOT PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiovascular Procedure KitDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2241-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
CT DAVINCI. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Obstetrical KitDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2242-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
DA VINCI PACK URO/PROSTATE. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2243-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2244-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
DAVINCI UROLOGY. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2245-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
GEN LAPAROSCOPY PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2246-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2247-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
GENERAL ROBOTIC PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Obstetrical KitDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2248-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
GS ENDOSCOPY PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2249-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
GYN LAPAROSCOPY PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Obstetrical KitDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2250-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
GYN ROBOTIC PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Obstetrical KitDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2251-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
HVI CARDIAC ROBOT PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiovascular Procedure KitDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2252-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
LAP CHOLE PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2253-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
LAPAROSCOPIC GYN. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2254-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2255-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
LAPAROSCOPY PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2256-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
LAVH PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Obstetrical KitDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2257-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
MAJOR THORACOSCOPY BASIN. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2258-2025